BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR NAR SCRO 16CM

    MDR report key: 7948015 · Received October 9, 2018

    Report

    Report Number
    2125050-2018-00725
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    September 3, 2018
    Report Date
    October 8, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE PROSTHESIS. IF THE EXPLANTED DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. QUALITY REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE REVEALED NO SIGNIFICANT TRENDS FOR LOT 4203569. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION, BROKEN PUMP. ADDITIONAL INFORMATION INDICATED THE PUMP BODY WAS MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788943 TITAN OTR NAR SCRO 16CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9161022 4203569

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other